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Vaccines, Blood & Biologics

Record of Telephone Conversation - Cervarix, October 7, 2009 PM

System Info - 107183  SHONE, DEANNA   07-Oct-2009 14:29:26  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  07-OCT-2009 02:17 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  ROBIN LEVIS

Telecon Summary:

CMC PMC

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

Sent: Wednesday, October 07, 2009 2:17 PM
To: 'byron.a.bravo@gsk.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'Matt.Whitman@gsk.com'
Subject: RE: Cervarix - CMC PMC

In regard to item 2, we acknowledge your October 2, 2009, commitment (as per Cynthia D'Ambrosio's email).

In regard to item 1, we clarify that long term study results are being requested for -------(b)(4)------- only. If you do, at some point, change the -------------------------(b)(4)--------------------------, it will be necessary to submit those data to the BLA.

Please state your commitment to the following postmarketing commitments:


---------------------(b)(4)-------------------------------------------------------------------------         -----------------------------------------------------------------------------------------------   ---------------------------------------------------------------------------------------------------------  --------------------------------------------------------------------------------------------------- ------

---------------------(b)(4)-----------------------------------------------------------------------------   ----------------------------------------------------------------------------------------------------          -----------------------------------------

 

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